FLEXIBLADE— 510(k) K984101

Substantially Equivalent

Arco Medic , Ltd.

FDA 510(k) clearance K984101 for FLEXIBLADE, Substantially Equivalent on 1999-09-03. Applicant: Arco Medic , Ltd..

Clearance details

Applicant: Arco Medic , Ltd.
Product code: Code CCW
Advisory panel: Anesthesiology
Date received: 1998-11-17
Decision date: 1999-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ra'Ananna 43373, IL

Download summary PDF View on FDA.gov ↗

Adverse events under product code CCW

product code CCW

Death: 31
Injury: 136
Malfunction: 3,703
Other: 1
Total: 3,871

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.